AHWON'S IPL SYSTEM

K102857 · Ahwon Medi Instrument Co., Ltd. · ONF · Jan 14, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102857
• Device Name: AHWON'S IPL SYSTEM
• Applicant: Ahwon Medi Instrument Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Jan 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ahwon RPL, R2PL system intended use for in Surgical, Asthetic and Cosmetic Application in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.

Device Story

RPL/R2PL are Intense Pulsed Light (IPL) systems for dermatological applications. Device utilizes a computer-controlled power supply and xenon lamp to generate light pulses of specific duration, intensity, and spectral distribution. Light is emitted through a sapphire filter on a handpiece when the operator presses a button. System includes two handpieces, each offering two selectable wavelengths. Integrated cooling system maintains safe temperatures for the treatment head and system. Operated by clinicians in a professional setting. Output consists of filtered light pulses targeting specific skin conditions. Clinical benefit includes non-invasive treatment of dermatological lesions and hair reduction.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1 (General requirements for safety) and IEC 60601-1-2 (Electromagnetic compatibility). No clinical data provided.

Technological Characteristics

IPL system using xenon lamp source; sapphire filters; computer-controlled power supply; integrated cooling system. Complies with IEC 60601-1 and IEC 60601-1-2 standards. Two handpieces with selectable wavelengths ranging from 415nm to 1200nm.

Indications for Use

Indicated for patients with skin types I-IV for the treatment of acne vulgaris, melasma, ephelides, port wine stains, rosacea, hair reduction/removal, and vascular lesions.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• GSD IPL System (K091664)
• StrataPulse IPL system (K090837)

Submission Summary (Full Text)

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# Summary of safety and effectiveness

In accordance with Section 513 (1) of the SMDA as defined in 21CFR part 807.3, this summary is submitted to obtain Pre-market 510 (K) notification.

### 1. Submitter

JAN 1 4 2011

Ahwon Medi Instrument Mr. Young Lee, President 187-7 Dodang Dong, WonMi gu, Buchen, Kyunggi do, Korea 420 806 Tel: [phone] Fax [phone] e mail: [e-mail]

### 2. U.S Agent / Contact person.

Mr. Young Chi, President Bio-Med USA Inc ( Reg Nr. 2246683 ) 111 Ellison street, Paterson, NJ 07505. U.S.A Tel: [phone] Fax [phone] e mail: [e-mail]

#### 3. Name of Device

| Trade name | : RPL™ System, R2PL ™ System |
|----------------------|--------------------------------------------------------------------------|
| Classification name | : Powered, light based Non Laser Surgical Instrument with thermal effect |
| Common or usual name | : Intense Pulsed Light System |
| Regulation | : 880.4810 |
| Class | : II |
| Product code | : ONF |

#### 4. Substantial Equivalence ( Identification of legally Marketing device )

#### Predicate device

| GSD IPL System | K091664 |
|------------------------|---------|
| StrataPulse IPL system | K090837 |

The Ahwon's RPL, R2PL system are substantially equivalent with other already cleared and marketing device at design, function, intended to use, treatment profile and performing.

## 5. Device Description.

The Ahwon's RPL, R2P1 are IPL ( Intense pulsed light) system, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand Piece, and composed

Main Board, unit LCD monitor controlled by computer Hand pieces Cooling system

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This device uses computer controlled Power supply and filter to generate light pulses of prescribed duration, intensity and spectral distribution. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures.,

The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system.

This system has two hand pieces and each hand piece has 2 wavelengths to choose from. at the end of the Hand Piece, there is a sapphire filter and light is emitted when the button is pressed.

And manufactured in accordance with both mandatory and voluntary standard included

IEC60601-1 Medical Electrical equipment-part 1, General requirement for safety amendment 2.1995 IEC60601-1-2 Electro magnetic compatibility test ED 2:2001 Amendment 1 : 2004 ED2:1 Consolidated with amendment 1:2004

### General Description attached

## 6. Intended use/Indication for use.

The Ahwon RPL, R2PL system intended use for in Surgical, Asthetic and Cosmetic Application in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.

| Treatment | Wave length | |
|---------------------|--------------|--------------|
| | RPL | R2PL |
| Acne, Vulgaris | | 415nm-950nm |
| Melasma, Ephelides. | 560nm-1200nm | 560nm-950nm |
| P.W.S/ Rosacea | 590nm-1200nm | 590nm-1200nm |
| Melasma/ | 640nm-1200nm | 640nm-1200nm |
| Hair Removal/ | 695nm-1200nm | 695nm-1200nm |
| Vascular Lesions | | |

#### 7. Conclusion

The Ahwon RPL/R2PL Intense Pulsed Light system, in this submission, is substantially Equivalent to several already cleared Predicate Device in respect to intended use, function, Technology, Principal operation and Performance.

So, it does not raise any additional concerns regarding safety and Effectiveness.

End of summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the border.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ahwon Medi Instrument Co., Ltd. % Bio-Med USA Inc. Mr. Young Chi. President 111 Ellison Street Paterson. New Jersey 07505

JAN 1 4 2011

Re: K102857

Trade/Device Name: Ahwon IPL System -- Model RPL, R2PL Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II

Product Code: ONF Dated: December 30, 2010 Received: January 04, 2010

Dear Mr. Chi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Young Chi. President

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for use statement

| 510 (K)number | : K102857 | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------------------------------------|
| Device name | : Ahwon IPL system model RPL, R2PL | | |
| Indication for use | : The Ahwon RPL, R2PL system intended use for in Surgical, Asthetic and Cosmetic Application<br>in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with<br>different wavelengths to skin types I-IV. | | |
| WaveLengths | Model RPL | WaveLengths | Model R2PL |
| | | 415-950nm | Acne, vulgaris, |
| 560-1200nm | Melasma,Ephelides | 560-950nm | Melasma, Ephelides |
| 590-1200nm | Port wine stains, Rosacea | 590-950nm | Port wine stains, Rosacea |
| 640-1200nm | Melasma, | 640-1200nm | Melasma, |
| 695-1200nm | Hair reduction/removal<br>Vascular lesions. | 695-1200nm | Hair reduction/ Removal<br>Vascular lesions. |

Prescription use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------X (Part 21 CFR 801 Sub part D)

Over the counter use Part 21 CFR801 Sub part C)

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUED ON ANOTHER PAGES IF NEEDED

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Concurrence of CDRH, office of Device Evaluation (ODE)

Neil R. Ogden for B. Xong
(Division Sign-OM)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K102857

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